BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CORE DISPOSABLE INSUFFLATION TUBING

    K Number: K901413 · Decision Sep 24, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    12
    Applicant Total
    23
    Review Days
    182

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    Basic Information

    Device Name
    CORE DISPOSABLE INSUFFLATION TUBING
    K Number
    K901413
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Core Dynamics, Inc.
    Date Received
    March 26, 1990
    Decision Date
    September 24, 1990
    Product Code
    HES
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HES Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)

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    Other Clearances by Core Dynamics, Inc.

    K Number Device Name
    K992250 CORE AUDIBLE TROCAR II
    K992190 CORE POUCH
    K955490 LAPAROSCOPIC KNITTER
    K953903 LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MM
    K953409 LAPAROSCOPIC TROCAR
    K950457 CANNUAL AND TROCAR, SUPERPUBIC
    K943172 CORE DYNAMICS' LAPAROSCOPIC SMOKE ELIMINATOR
    K935826 LAPAROSCOPIC/SUCTION/IRRIGATION PROBE
    K932118 ENDOSCOPIC TRANSMURAL SUTURE NEEDLE SET
    K932021 ENTREE CANNULA FASCIA ANCHORS
    Search all 23 clearances from Core Dynamics, Inc. →